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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

A new report released by the US Customs and Border Protection (CBP) on 9 January shows a dramatic increase in the amount of counterfeit pharmaceutical products seized by CBP during fiscal year (FY) 2011.

Pharmaceutical products represented the third most popular category of commodities seized by CBP during FY 2011, representing 1,239 seizures worth $16.9 million, or 9% of all the value of all goods seized. This represents a three-fold increase over 2010, when CBP seized 433 product shipments worth $5.6 million, or 3% of the value of all products seized.

The Manufacturers Suggested Retail Price (MSRP) of all pharmaceutical products seized amounted to $24.8 million in FY 2011.

When ranked by category, pharmaceuticals represented 28% of the "consumer safety and critical technology" category. This represents a marked increase for pharmaceuticals over FY 2010 when pharmaceuticals represented just 13% of that same category.

&nbsp;"CBP and ICE [Immigrations and Customs Enforcement] conducted a number of successful enforcement efforts in FY 2011 targeting counterfeit pharmaceuticals," noted the report.

Certain countries were listed by the report as being the most notorious origins of counterfeit products. Pharmaceutical products were seized from China ($6.9 million), India ($3.9 million), Pakistan ($3.4 million) and Hong Kong ($1.7 million) during FY 2011.

The report noted that while the overall percentages of products seized from countries had remained relatively stable, the value of certain products originating from countries had increased. "The value of pharmaceutical seizures from China increased by more than $4.3 million" in FY 2011 according to CBP.

Pharmaceutical counterfeiting seizures vaulted India and Pakistan into CBP's "Top Ten Source Countries," accounting for "86% of the value of IPR [Intellectual Property Rights] seizures from India and 85% of the value of IPR seizures from Pakistan."